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COVID-19 COVERAGE FOR LIFE SCIENCE COMPANIES

Dates covered in this issue: 05/22/20 – 05/28/20

Click here to see our comprehensive breakdown providing up-to-date life science information on these topics.

    • COVID-19 related corporate messaging
    • Medical conference tracker
    • Investment banking conference tracker
    • Capital markets update
    • Strategic/business development transactions
    • Select news flow from the FDA, EMA and SEC websites

Below we provide a snapshot of the above plus additional information on other news/feedback from the Westwicke team.


In this issue:

Publics Mentioned: 4507-JP, AKTX, ARGX, ARNA, ARVN, ATRA, BCRX, BMY, EARS, GERN, GILD, IOVA, LLY, MRSN, NRNS, NVAX, ONCE-SE, RCUS, REGN, VIE

 

Privates Mentioned: AbCellera , Alvaxa Biosciences, Arvelle Therapeutics, Exscientia, Insitro, Jiangsu New Element Pharmaceutical , Monte Rosa Therapeutics, Palvella Therapeutics, Praha Vaccines, Q32 Bio, Repare Therapeutics, Sensei Biotherapeutics, Tetra Therapeutics, ViaCyte


COVID-19 Related Corporate Messaging

    • 5/29/2020: Arvinas (ARVN) announced in an 8-K filing that, based on an interim update on ARV-471 in metastatic ER+/HER2- breast cancer, the dose escalation portion of the Company’s Ph 1/2 trial continues with no DLT observed to date and limited impact on patient enrollment. Link to filing here
    • 5/29/2020: Akari Therapeutics (AKTX) announced in an earnings PR that clinical trial sites for its Ph 3 trial in pediatric patients with HSCT-TMA will be delayed to later in 2020. The Company also announced that enrollment for its Ph 1/2 trial in patients with atopic keratoconjunctivitis (AKC) has been paused; an interim update for that trial is expected middle of 2020 Link to PR here
    • 5/28/2020: Geron (GERN) announced in an earnings PR that it is updating guidance for 2020 operating expenses from $70M to $75M. Link to PR here
    • 5/28/2020: Oncopeptides (ONCE-SE) announced in a trial-specific update PR that it is resuming enrollment for several trials in its melphalan clinical program, include its Ph 2 BRIDGE trial in patients with reduced renal function, it’s Ph 1/2 ANCHOR trial of melflufen in multiple myeloma, and its AL amyloidosis trial. Link to PR here
    • 5/26/2020: Auris Medical (EARS) announced in a trial-specific update PR that it has resumed enrollment for its Ph 2 TRAVERS trial of AM-125 in patients with acute peripheral vertigo. Link to PR here
    • 5/26/2020: Arena Pharmaceuticals (ARNA) announced in an earnings PR that it is withdrawing guidance on its Ph 2b CULTIVATE trial of etrasimod in patients with Crohn’s disease, including site activation and enrollment. The company remarked that they are considering options to help facilitate the availability of topline data in 2021. The Company also announced that its Ph 1 trial of ADP418 in patients with HF is temporarily paused, but is still guided for topline data in 4Q20. Link to PR here
    • 5/25/2020: Novavax (NVAX) announced in a trial-specific update PR that the first patients have been enrolled in its Ph 1/2 trial of NVX-CoV2373 in patients with COVID-19. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020. Link to PR here

Medical Conference Tracker

The following medical conferences provided updates on the status of their events (for full list click here):

    • International Academy of Cardiology Annual Scientific Sessions: Cancelled (Original Dates: July 24-26, 2020)
    • Nordic Life Science Days: Postponed (Original Dates: September 8-10, 2020; New Dates: April 19-21, 2021)

Investment Banking Conference Tracker

The following investment banking conferences provided updates on the status of their events (for full list click here):

    • Credit Suisse Summer Biotech Conference: Postponed (Original Dates: June 22-24, 2020)

Capital Markets Update

Private Offerings

    • Palvella Therapeutics announced the closing of an oversubscribed $45 million Series C financing with participation from CAM Capital, Samsara BioCapital, BVF Partners L.P., Adams Street Partners, Opaleye Management, Ligand Pharmaceuticals (Nasdaq: LGND), Agent Capital, BioAdvance and Nolan Capital. (5/28/20)
    • AbCellera closed a $105 million Series B financing led by OrbImed and current investor DCVC Bio. The investor syndicate includes Viking Global Investors, Peter Thiel, Founders Fund, Eli Lilly and Company, University of Minnesota, and Presight Capital. (5/27/20)
    • Q32 Bio, incubated by Atlas Venture with foundational science from renowned researchers in immunology, announced a $46 million series A financing led by Atlas Venture. OrbiMed Advisors, Abingworth, Sanofi Ventures, University of Colorado and Children’s Hospital Colorado Center for Innovation also participated in the financing round. (5/27/20)
    • Jiangsu New Element Pharmaceutical (Atom Bioscience) completed a $30 million Series B led by Livzon Pharmaceutical and Sequoia Capital China Fund, followed by Kaitai Capital and Dachen Caizhi. (5/27/20)
    • Insitro, a machine-learning drug discovery company, announced it raised $143 million in an oversubscribed Series B financing led by Andreessen Horowitz, with participation from new investors CPP Investments and funds and accounts advised by T. Rowe Price Associates, Inc. as well as funds managed by BlackRock, Casdin Capital, HOF Capital, WuXi AppTec’s Corporate Venture Fund, and other undisclosed investors. Current investors ARCH Venture Partners, Foresite Capital, GV, Third Rock Ventures, Two Sigma Ventures, and Alexandria Venture Investments also participated in the financing. (5/26/20)
    • AI drug discovery company, Exscientia, announced a $60 million Series C financing led by Novo Holdings. Evotec, Bristol Myers Squibb and GT Healthcare Capital also participated in the round. (5/26/20)
    • Arvelle Therapeutics announced it closed the final tranche of its Series A financing round, which was triggered by the EMA’s recent MAA acceptance announced in March 2020. The final tranche of $42.7m, representing 32% of the initial total Series A commitment of $133.3m, along with $74.5m in previously funded product financing, brings the total capital raised to $207.8m. Series A investors include NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital, KB Investments and members of management. (5/26/20)
    • Monte Rosa Therapeutics exited stealth mode with a $32.5 million Series A commitment from founding investor Versant Ventures and New Enterprise Associates. Monte Rosa was launched from Ridgeline, Versant’s Discovery Engine based in the Basel Technology Park. (5/26/20)
    • ViaCyte announced the close of a $27 million private financing, part of the Series D preferred stock financing entered into in late 2018. Investors included Bain Capital Life Sciences, TPG Capital, RA Capital Management, Sanderling Ventures, and several individual supporters of the Company. (5/26/20)
    • CalciMedica announced it raised $15 million in a Series C financing round led by Valence Life Sciences, with participation from Bering Capital, Mesa Verde Venture Partners and Sanderling Ventures. (5/22/20)

Public Offerings

    • argenx (EURONEXT & NASDAQ: ARGX) priced a global offering of ADSs in the US and certain other countries outside of European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. The Company anticipates total gross proceeds of approx. $750 million from the sale of 2.6 million ADSs at a price of $205/ADS and the sale of 1.1 million ordinary shares at a price of €186.52/sh. The deal was done through JP MOrgan, COwen and BofA Securities and is expected to close on June 1. (5/28/20)
    • Iovance Biotherapeutics (NASDAQ: IOVA) priced a public offering of 16.9 million shares of common stock at $31/sh for total gross proceeds of approx. $525 million. The deal was done through Jefferies and Goldman Sachs and is expected to close June 2. (5/28/20)
    • Arcus Biosciences (NASDAQ: RCUS) priced a public offering of 11.0 million shares of common stock at $27.50/sh for total gross proceeds of approx. $302.5 million. The deal was done through Citigroup. SVB Leerink and Evercore ISI and is expected to close June 2. (5/28/20)
    • Arena Pharmaceuticals (NASDAQ: ARNA) priced a public offering of 5.5 million shares of common stock at $50/sh for total gross proceeds of approx $275 million. The deal was done through BofA Securities, Citigroup and SVB Leerink and is expected to close June 1. (5/28/20)
    • Mersana Therapeutics (NASDAQ: MRSN) priced a public offering of 8.0 million shares of common stock at $19/sh for total gross proceeds of approx. 152 million. The deal was done through Cowen and SVB Leerink and is expected to close June 2. (5/28/20)
    • Marinus Pharmaceuticals (NASDAQ: MRNS) priced a public offering of 16.0 million shares of common stock at $2.50/sh for total gross proceeds of approx. $40 million. The deal was done through Cowen and Cantor Fitzgerald and is expected to close on June 2. (5/28/20)
    • Atara Biotherapeutics (NASDAQ: ATRA) priced a public offering of 12.6 million shares of common stock at $11.32/sh and, to certain investors, pre-funded warrants to purchase 2.9 million shares of common stock at $11.3199 for total gross proceeds of approx. $175.5 million. The deal was done through Citigroup, Cowen and Evercore ISI. (5/27/20)
    • Viela Bio (NASDAQ: VIE) priced a public offering of 3.6 million shares of common stock at $47/sh for total gross proceeds of approx. $169 million. The deal was done through Morgan Stanley, Goldman Sachs, Cowen and Guggenheim and is expected to close June 1. (5/27/20)
    • BioCryst Pharmaceuticals (NASDAQ: BCRX)  priced a public offering of 18.7 million shares of common stock at $4.50/sh and, to certain investors, pre-funded warrants to purchase 3.5 million shares of common stock at $4.49 for total gross proceeds of approx. $100 million. The deal was done through JP Morgan and Piper Sandler and is expected to close on June 1. (5/27/20)
    • Regeneron Pharmaceuticals (NASDAQ REGN) priced a public secondary offering of 11.8 million shares of common stock held by Sanofi at a price of $515/sh. Regeneron also agreed to purchase 9.8 million shares directly from Sanofi, representing an aggregate purchase amount of $5 billion. The deal was done through BofA Securities and Goldman Sachs. (5/26/20)
    • Geron Corp. (NASDAQ: GERN) priced a public offering of 107.0 million shares of common stock and pre funded warrants to purchase 8.3 million shares of common stock, together with accompanying warrants to purchase 57.7 million shares of common stock. Total gross proceeds are expected to be approx. $150 million. The deal was done through Stifel and MTS Health Partners. (5/22/20)

Strategic/Business Development Transactions

5/27/20: NVAX, Praha Vaccines (Private)

Novavax will acquire Praha Vaccines a.s., part of the Cyrus Poonawalla Group, in an all cash transaction of approximately $167 million. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate.

5/27/20: Sensei Biotherapeutics (Private), Alvaxa Biosciences (Private)

Sensei will acquire Alvaxa Biosciences and its existing camelid nanobody libraries, expertise in nanobody discovery, as well as its partnership with Hope Farms, LLC, a United States Department of Agriculture (USDA) licensed Alpaca farm, for the generation of future alpaca-derived nanobodies.

5/27/20: GILD, RCUS

Arcus will receive $375 million upon closing, consisting of a $175 million upfront payment and a $200 million equity investment from Gilead. Arcus is eligible to receive up to $1.225 billion in opt-in and milestone payments with respect to its current clinical product candidates. Gilead will gain access to Arcus’s current and future investigational immuno-oncology products through the agreement, as Gilead continues to expand its presence in the field.

5/26/20: Tetra Therapeutics (Private), 4507-JP

Tetra will become a wholly owned subsidiary of Shionogi, and Shionogi will obtain global rights to Tetra’s entire portfolio of compounds for the treatment of brain disorders associated with cognitive and memory deficits, notably BPN14770, a selective inhibitor of phosphodiesterase‐4D (PDE4D). Based on the achievement of certain predetermined regulatory and commercial milestones the total transaction value may be up to $500 million.

5/26/20: Repare Therapeutics (Private), BMY

The companies will leverage Repare’s proprietary, CRISPR-enabled genome-wide synthetic lethal target discovery platform, SNIPRx®, to jointly identify multiple synthetic lethal precision oncology targets for drug candidates. Repare will grant BMS exclusive worldwide rights to develop and commercialize therapeutics for select validated synthetic lethal precision oncology targets discovered under the collaboration. BMY will make an upfront payment of $65 million which includes a $15 million equity investment in Repare. Repare will be eligible to receive up to approximately $3 billion in license fees, discovery, development, regulatory and sales-based milestones, in addition to royalty payments on net sales of each product commercialized by BMY.

5/22/20: AbCellera (Private), LLY

Agreement with Eli Lilly and Company (Lilly) on the discovery of antibodies for up to nine Lilly-selected therapeutic targets. Lilly will have the rights to develop and commercialize therapeutic products resulting from the collaboration. AbCellera received an up-front payment and will receive research payments for the non-COVID-19 targets. AbCellera is also eligible to receive pre-clinical, clinical, and commercial milestones and tiered royalties on future sales.


Select News Flow from the FDA, EMA and SEC Websites

    • 5/28/2020: The FDA issued immediately effective guidance explaining how the coronavirus disease public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications. The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BSUFA) and the Generic Drug User Fee Amendments (GDUFA). Link to guidance here
    • 5/27/2020: Health Canada issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19. The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19. The IO has dropped administrative requirements for non-significant changes during a clinical trial; only changes that are significant now need approval. Also, trials may now engage a broader range of investigators and obtain informed consent in a variety of ways. Link to news here

Other News/Feedback

Although highlighted above, we thought it was worth calling out the updated FDA guidance specific to upcoming PDUFA dates:

The FDA has converted many previously scheduled PDUFA and BSUFA meetings from in-person to virtual at the same dates and times as originally scheduled. FDA says it is still accepting new meeting requests “as per usual practice,” but notes that it may provide a written response only in some circumstances and may reevaluate the format of some pending meetings.

FDA notes that it will still aim to conduct initial investigational new drug application (IND) 30-day safety reviews and respond to “other important safety issues that may emerge during IND development.” FDA also explains that it will communicate directly with sponsors or applicants if it anticipates missing a goal date, but notes that both the “PDUFA and BSUFA goal letters do not contemplate FDA extending or changing user fee goal dates,” except in response to submission that would trigger a clock extension. Link to guidance here

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